Ovulation induction and luteal phase support with GnRH agonists in in vitro fertilizatio
- Conditions
- IVF (In vitro fertilization) or ICSI (intracytoplasmic sperm injection) protocol with embryo transfer planned on the same cycle.MedDRA version: 21.0Level: PTClassification code: 10080951Term: Assisted reproductive technology Class: 100000004865Therapeutic area: Phenomena and Processes [G] - Biological Phenomena [G16]
- Registration Number
- CTIS2023-505126-34-00
- Lead Sponsor
- Assistance Publique Hopitaux De Paris
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 652
Patients requiring conventional IVF or IVF with sperm injection (ICSI) from a partner or donor under the conditions defined by French law, after agreement by a multidisciplinary consultation meeting, Signed informed consent, Social security affiliation (excluding AME), Patients aged 18 to 39 included, First or second attempt at IVF or ICSI, BMI < 35 kg/m2, AMH > 1 ng/ml (= 7 pmol/L) and/or antral follicle count = 8, AMH <5 ng/ml and/or antral follicle count <40, Antagonist protocol (programmed or not), Treatment with daily recombinant FSH, Initial dose of daily recombinant FSH between 75 and 450 I
Patient or partner with HIV, HBV or HCV, Current participation in another therapeutic interventional trial on the day of inclusion, Patients who do not speak or understand French, ICSI with sperm from testicular biopsy, Pre-implantation diagnosis, Hypogonadotropic hypogonadism (amenorrhea or spaniomenorrhea with basal LH <1.2 IU/L), History of severe ovarian hyperstimulation syndrome (OHSS), Unoperated hydrosalpinx, Intracavitary polyps or myomas deforming the cavity, Known hypersensitivity to the investigational drugs and/or their excipients (human chorionic gonadotropin, progesterone, nafarelin acetate, GnRH, GnRH analogues, mannitol, sodium chloride, water for injection, glacial acetic acid, sodium hydroxide and/or hydrochloric acid, sorbitol, purified water, benzalkonium chloride, sunflower oil, soy lecithin, gelatin, glycerol, titanium dioxide (E171), methionine, poloxamer 18, phosphoric acid), Gynaecological bleeding or genital haemorrhage, Tumors of the hypothalamus or pituitary gland, Impaired renal function, Major characterized depressive episode in progress, Ovarian hypertrophy or cysts unrelated to polycystic ovary syndrome, Severe adenomyosis requiring a long protocol, Carcinoma of the ovary, uterus or breast, Progressive thromboembolic events, Severe impairment of liver function, Breast-feeding women, Patients under safeguard of justice, guardianship or curatorship
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method